Coupling device for coupling a rod to a bone anchoring element and method of manufacturing the same

ABSTRACT

A coupling device for coupling a rod to a bone anchoring element includes a receiving part with a head receiving portion for receiving a head of the bone anchoring element, a rod receiving portion for receiving the rod, a downwardly facing surface, and an upwardly facing surface below and monolithically formed with the downwardly facing surface, and a locking member movable relative to the receiving part from a first position where the head is insertable into the head receiving portion to a second position where the head is prevented from being removed from the head receiving portion. At least part of the locking member is held to the receiving part between the downwardly and upwardly facing surfaces, and wherein the receiving part and the locking member are only separable from one another by permanently deforming or damaging at least one of the receiving part or the locking member.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.17/879,685, filed Aug. 2, 2022, which claims priority to and the benefitof U.S. Provisional Patent Application No. 63/229,231, filed Aug. 4,2021, the contents of which are hereby incorporated by reference intheir entirety, and claims priority from European Patent Application EP21 189 722.8, filed Aug. 4, 2021, the contents of which are herebyincorporated by reference in their entirety.

BACKGROUND Field

The application relates to a coupling device for coupling a rod to abone anchoring element and to methods of manufacturing and using thesame. In particular, the invention relates to a coupling device thatforms part of a polyaxial bone anchoring device.

Description of Related Art

Various types of polyaxial bone anchoring devices are known in the art.Usually, a polyaxial bone anchoring device includes a coupling deviceand a bone anchoring element with a head that is pivotably received inthe coupling device and that can be locked at a desired angle relativeto the coupling device. The coupling device also receives a rod that isconfigured to connect the polyaxial bone anchoring device to a furtherbone anchoring device. U.S. Pat. No. 9,339,302 B2, for example,describes such a polyaxial bone anchoring device. The document alsodescribes a two-part locking member for a polyaxial bone anchoringdevice that is manufactured using an additive manufacturing method. Thetwo-part locking device is made as a monolithic piece includingpredetermined breaking areas that break when a certain torque isapplied. Thereby the parts become separated.

US 2017/0367843 A1 describes various interbody fusion spacers or cagesfor insertion between adjacent vertebrae. The implantable devices may bemanufactured using a selective laser melting (SLM) technique, a form ofadditive manufacturing. By means of this, intervertebral cages areformed of multiple, interconnected parts that do not require additionalexternal fixation elements to keep together.

U.S. Pat. No. 11,006,981 B2 describes a method of manufacturing asurgical implant that includes simultaneously forming a first componentand a second component of the surgical implant. The surgical implant isdesigned to be manufactured via methods of additive manufacturing, i.e.,layer-by-layer techniques. A first component of the surgical implant mayhave a hollow interior portion and at least one opening, and a secondcomponent may have a head portion disposed within the hollow interiorportion and a shaft portion extending through the at least one opening,wherein the head portion is configured and dimensioned to be larger thanthe at least one opening and therefore unable to pass therethrough. Bymeans of this, a polyaxial implant can be provided.

SUMMARY

It is an object of the invention to provide a coupling device forcoupling a bone anchoring element to a rod, in particular in a polyaxialmanner, where the coupling device is improved and/or is an alternativecompared to conventional coupling devices, and methods of manufacturingand using such a coupling device.

According to an aspect of the invention, the coupling device includes areceiving part having a head receiving portion for receiving a head ofthe bone anchoring element and a rod receiving portion for receiving therod, and a locking member movable relative to the receiving part betweena first position in which the head is insertable into the head receivingportion and a second position in which the head is prevented from beingremoved from the head receiving portion, wherein the receiving part andthe locking member are inseparably interconnected with each other.

The receiving part and the locking member are interconnected parts whichare movable relative to each other, but are inseparable prior to usingthe coupling device and/or during use. In other words, under conditionsof use prior or during surgery and in the implanted state, the receivingpart and the locking member cannot be separated from each other withoutdamaging or destroying the coupling device (e.g., without plastically orotherwise permanently deforming or damaging at least one of thereceiving part or the locking member). Hence, the coupling device isfree from any separate fixation members that would otherwise keep thereceiving part and the locking member together. Compared toconventionally produced coupling devices, the coupling device accordingto embodiments of the invention may therefore include less parts. Inaddition, the parts are more safely secured together.

In particular, the coupling device according to embodiments of theinvention may be made using an additive manufacturing method, morespecifically, an additive layer manufacturing method. In such a method,the coupling device is built up by layer-wise deposition of a buildingmaterial, and solidifying or melting the material in each layer at thecross-section of the coupling device in the respective layer. A suitablemethod is, for example, selective laser sintering (SLS) or selectivelaser melting (SLM), in which the building material is a powder, such asa metal powder or a plastic powder, and a laser is used to melt thepowder. Alternatively, an electron beam may be used to melt the buildingmaterial. Also, other known methods of powder based three-dimensionalprinting in which layers of a powder material are deposited andsolidified by applying a binder material at positions corresponding tothe coupling device may be used. Still further additive manufacturingmethods, for example, fused deposition modeling (FDM) may also beapplied.

Hence, since it is possible to produce almost any shape with an additivemanufacturing method, the receiving part and the locking member may havecomplex shapes and/or may be interconnected in a manner that may bedifficult or impossible to manufacture conventionally. Thereby, animprovement with regard to the strength of the parts and an improvedtransfer of forces may be achieved.

In a particular embodiment, the receiving part and the locking membercan be built up as a monolithic unit. The receiving part and the lockingmember may be separated after they have been manufactured with theadditive manufacturing method. More specifically, the monolithic unitmay include a holding portion that facilitates holding of the monolithicunit with a tool to allow separation of the receiving part and thelocking member from the holding portion by cutting. This allows toprecisely separate the receiving part and the locking member atrespective positions suitable for permitting the locking member to moverelative to the receiving part after the separation step. As a result ofthe separation, the receiving part and the locking member form anintegrated unit.

It shall be noted that the additive manufacturing method, in particular,the additive layer manufacturing method, influences the appearance ofthe coupling device. For example, the layers may be visible on thesurface of a particular finished object, even if the integrated unitincluding the receiving part and the locking member is post-treated,such as polished, etched, coated or otherwise treated. It may also bepossible to identify traces of the laser or electron beam wheninspecting the fabricated object. Hence, the additive manufacturingmethod, in particular the additive layer manufacturing method, can bedistinguished on the basis of finished object compared to a conventionalsubtractive manufacturing method.

In a particular embodiment, the coupling device is configured to providea bottom-loading polyaxial bone anchoring device which allows insertionof the head of the bone anchoring element from the bottom end of thecoupling device. Alternatively, the coupling device may be designed fora top-loading polyaxial bone anchoring device in which the boneanchoring element is inserted from the top end of the receiving partinto the coupling device.

A polyaxial bone anchoring device according to embodiments of theinvention includes, in addition to the coupling device, a bone anchoringelement having a head and a shank, preferably wherein the head has aspherically-shaped outer surface portion.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages of the invention will become apparentfrom the description of embodiments by means of the accompanyingdrawings. In the drawings:

FIG. 1 shows a perspective exploded view of a first embodiment of apolyaxial bone anchoring device including a first embodiment of acoupling device.

FIG. 2 shows a perspective view of the polyaxial bone anchoring deviceof FIG. 1 in an assembled state.

FIG. 3 shows a cross-sectional view of the polyaxial bone anchoringdevice of FIGS. 1 and 2 , wherein the cross-section is taken in a planeextending perpendicular to a longitudinal axis of an inserted rod andthrough centers of legs of the coupling device.

FIG. 4 shows a perspective view from a top of the coupling device of thebone anchoring device shown in FIGS. 1 to 3 .

FIG. 5 shows a perspective view from a bottom of the coupling device ofFIG. 4 .

FIG. 6 a shows a cross-sectional view of the coupling device of FIGS. 4and 5 , the cross-section taken in a plane extending through centers oflegs of a receiving part of the coupling device and perpendicular to alongitudinal axis of a rod channel of the receiving part.

FIG. 6 b shows an enlarged view of a detail of FIG. 6 a.

FIG. 7 shows a perspective view from a top of a monolithic unitincluding the receiving part and a locking member of the coupling deviceof FIGS. 4 to 6 b and a holding portion for holding the monolithic unit.

FIG. 8 shows a perspective view from a bottom of the monolithic unit ofFIG. 7 .

FIG. 9 shows a top view of the monolithic unit of FIGS. 7 and 8 .

FIG. 10 shows a cross-sectional view of the monolithic unit of FIGS. 7to 9 , the cross-section taken in a plane along line A-A in FIG. 9 .

FIG. 11 a to FIG. 11 d show cross-sectional views of steps of assemblingthe polyaxial bone anchoring device according to the first embodiment.

FIG. 12 a to 12 f show perspective views of steps of moving the lockingmember relative to the receiving part of the coupling device accordingto the first embodiment with an instrument, and inserting and fixing therod.

FIG. 13 shows a perspective view of a second embodiment of the polyaxialbone anchoring device with a second embodiment of the coupling device inan assembled state.

FIG. 14 shows a cross-sectional view of a portion of the polyaxial boneanchoring device of FIG. 13 , the cross-section taken in a planeextending perpendicular to a longitudinal axis of an inserted rod andextending through center of legs of a receiving part of the couplingdevice.

FIG. 15 shows a cross-sectional view of a monolithic unit of thecoupling device according to the second embodiment of FIGS. 13 and 14 ,further including a holding portion, wherein the cross-section is takenin a plane perpendicular to a longitudinal axis of a rod channel of thereceiving part and extending through centers of the legs of thereceiving part.

FIG. 16 shows a cross-sectional view of an integrated unit that formsthe coupling device according to the second embodiment, in a stateseparated from the holding portion shown in FIG. 15 .

FIG. 17 shows a top view of the coupling device of FIG. 16 .

FIG. 18 shows a cross-sectional view of the coupling device of FIGS. 16and 17 , the cross-section taken in a plane along line B-B in FIG. 17 .

FIG. 19 shows a perspective view of a third embodiment of the polyaxialbone anchoring device with a third embodiment of the coupling device inan assembled state.

FIG. 20 shows a cross-sectional view of the polyaxial bone anchoringdevice of FIG. 19 , the cross-section taken in a plane extendingperpendicular to a longitudinal axis of an inserted rod and extendingthrough center of legs of a receiving part of the coupling device.

FIG. 21 shows a perspective view from a bottom of the coupling deviceaccording to the third embodiment, wherein the receiving part and alocking member of the coupling device are in a first position relativeto each other.

FIG. 22 shows a perspective view of the coupling device of FIG. 21 ,wherein the receiving part and the locking member are in a secondposition relative to each other.

FIG. 23 shows a cross-sectional view of the coupling device of FIG. 21 ,wherein the cross-section is taken in a plane including a central axisof the coupling device and arranged at an angle with respect to alongitudinal axis of a rod channel of the receiving part.

FIG. 24 shows a cross-sectional view of the coupling device of FIG. 22 ,wherein the cross-section taken in a plane extending perpendicular tothe longitudinal axis of the rod channel and extending through centersof the legs of the receiving part.

FIG. 25 shows a perspective view from a top of a monolithic unitincluding the receiving part and the locking member of the couplingdevice according to the third embodiment of FIGS. 19 to 24 , themonolithic unit further including a holding portion.

FIG. 26 shows a cross-sectional view of the monolithic unit of FIG. 25 ,wherein the cross-section is taken in a plane including the central axisof the coupling device and arranged at an angle relative to thelongitudinal axis of the rod channel.

FIG. 27 shows a perspective view of a fourth embodiment of the polyaxialbone anchoring device with a fourth embodiment of the coupling device.

FIG. 28 shows a cross-sectional view of the polyaxial bone anchoringdevice of FIG. 27 , the cross-section taken in a plane perpendicular toa longitudinal axis of an inserted rod and extending through centers oflegs of a receiving part of the coupling device.

FIG. 29 shows a perspective view from a top of the coupling deviceaccording to the fourth embodiment.

FIG. 30 shows a perspective view from a bottom of the coupling device ofFIG. 29 .

FIG. 31 shows a cross-sectional view of the coupling device of FIGS. 29and 30 , the cross-section taken in a plane including a central axis ofthe receiving part and extending through centers of legs of thereceiving part.

FIG. 32 shows a cross-sectional view of a monolithic unit including thereceiving part and a locking member according to the fourth embodiment,the monolithic unit further including a holding portion, thecross-section taken in a plane extending perpendicular to a longitudinalaxis of a rod channel of the receiving part and through centers of thelegs of the receiving part.

DETAILED DESCRIPTION

A polyaxial bone anchoring device according to a first embodiment isshown in FIGS. 1 to 3 . The bone anchoring device includes a boneanchoring element 1 having a shank 2 with a threaded portion and a head3. The head 3 has a spherically-shaped outer surface portion and, on itsside opposite to the shank 2, a recess 4 for engagement with a tool. Acoupling device 5 according to a first embodiment is provided forcoupling the bone anchoring element 1 to a rod 100. The polyaxial boneanchoring device further includes a fixation assembly 8 having a firstmember 9 and a second member 10 configured to be coupled to the firstmember 9.

Referring in addition to FIGS. 4 to 6 b, the coupling device 5 includesa receiving part 50 and a locking member 60 that are separate partswhich are interconnected with each other. In greater detail, thereceiving part 50 and the locking member 60 are interconnected in amanner such that they are movable relative to each other but cannot beseparated from each other. More specifically, the receiving part 50 andthe locking member 60 cannot be separated from each other withoutdamaging or destroying the coupling device 5. Hence, the coupling device5 forms an integrated unit including the receiving part 50 and thelocking member 60. In this embodiment, the receiving part and thelocking member is each a monolithic part.

The receiving part 50 has a first end or top end 5 a and an oppositesecond end or bottom end 5 b, and is substantially cylindrical with alongitudinal axis C extending through the top end 5 a and the bottom end5 b. A coaxial passage 51 is formed in the receiving part 50 thatextends from the top end 5 a to the bottom end 5 b where the passagedefines an opening 52. The passage narrows towards the opening 52, forexample, with a conically-shaped section 53 that is configured tocooperate with a portion of the locking member 60, as described ingreater detail below. The width or diameter of the opening 52 is greaterthan a greatest width of the head 3 of the bone anchoring element 1.This permits insertion of the head 3 from the bottom end 5 b into thereceiving part 50. Further, the receiving part 50 defines a recess 54starting at the top end 5 a and extending in the direction of the bottomend 5 b. By means of the recess 54, two free legs 55 are formed that areopen towards the top end 5 a and that define a channel for receiving therod 100. A bottom of the recess 54 is configured to receive a portion ofthe locking member 60 therein and provides space for the locking member60 to move in an axial direction. At a distance from the top end 5 a,the passage 51 widens into a circumferentially extending recess 56 oneach of the legs 55 that serve for receiving radially protruding wings91 of the first member 9 of the locking assembly 8 therein. At one endof each of the circumferential recesses 56, an abutment 56 a is formedthat prevents the wings 91 from moving out of the recess 56, asexplained in greater detail below. At the opposite end, the recess 56 isopen towards the rod channel. It shall be noted that such an abutment 56a is formed at the end of each of the recesses in a specificcircumferential direction such that when the first member 9 is insertedand rotated in this direction, in the clockwise direction in the exampleshown, the circumferentially leading end of each wing 91 abuts in therespective recess 56 against the corresponding abutment 56 a. The heightof the circumferential recesses 56 is greater than an axial height ofthe wings 91 to facilitate the insertion of the fixation assembly.

At the center of each of the legs 55 at a distance from the top end 5 a,a recess 57 is formed that extends fully through the receiving part 50from the outside to the passage 51 to permit a portion of the lockingmember 60 to extend therethrough. The recesses 57 may have asubstantially pentagonal or house-like contour, with a roof portionhaving a top oriented towards the first end 5 a of the receiving part50. An axial height of the recesses 57 is such that a correspondingportion of the locking member 60 can move to some extent therein in theaxial direction.

The passage 51 can have various portions, and does not need to have aconstant inner diameter. Specifically, between the recesses 57 and therecesses 56, the passage 51 has a reduced diameter section with a groove58, preferably with a rounded cross-section, for example a sphericalsegment-shaped cross-section, at a lowermost position of the reduceddiameter section. The groove 58 serves for receiving a portion of thelocking member 60 when the locking member 60 is at an insertionposition.

Moreover, the receiving part 50 includes a tool engagement protrusion 59on each of the legs 55 at a center thereof in the circumferentialdirection and above the recesses 57. For example, the tool engagementprotrusions 59 may have a roof-shaped upper side 59 a.

The locking member 60 has a top end 6 a and an opposite bottom end 6 b.The bottom end 6 b is configured to face the opening 52 in the receivingpart 50. Between the top end 6 a and the bottom end 6 b, the lockingmember 60 has a shape that is substantially cylindrical, except for theportions that are configured to extend out of the passage 51 of thereceiving part 50. An outer width of the cylindrical portion of lockingmember 60 is smaller than the inner width of the passage 51, so that thelocking member 60 can move to some extent within the passage 51.Adjacent to the bottom end 6 b, a hollow interior head receiving section61 is formed that provides a seat for the head 3 of the bone anchoringelement 1. The head receiving section 61 has a shape and in particularan inner diameter that is adapted to the outer diameter of the head 3 ofthe bone anchoring element 1. In particular, the head receiving section61 is configured to extend over a section of the head 3 with a greatestdiameter. An opening is defined at the bottom end 6 b through which thehead 3 of the bone anchoring element 1 can enter into the head receivingsection 61. In particular, the head receiving section 61 is flexible andcan expand when the head 3 is inserted. Moreover, the head receivingsection 61 is configured to be compressed by an external force to clampand finally lock the head 3 in the head receiving section 61. To achievethe flexibility, a plurality of slits 62 that are open towards thesecond end 6 b may be provided. An end portion 62 a of each the slitsmay be enlarged. Various shapes may be used for the end portion 62 a,such as a circular or a rounded triangular shape, or any other shapethat achieves a suitable flexibility.

Adjacent to the bottom end 6 b, the outer surface of the locking member60 has a narrowing portion 63, in the example, a conically taperingportion 63 that is configured to cooperate with the narrowing portion 53of the receiving part 50. When the narrowing portions 53, 63 of thereceiving part 50 and the locking member 60, respectively, cooperate, aninwardly directed force is generated that compresses the head receivingsection 61. Adjacent to the top end 6 a, a recess 64 is provided thathas substantially flat and substantially parallel sidewalls and, as seenin the cross-sectional views of FIGS. 3 and 6 a, a substantiallyV-shaped bottom that provides a rod support surface 64 a. The recess 64is aligned with the recess 54 of the receiving part 50 and defines achannel axis L of the rod channel (see FIG. 9 ) that is perpendicular tothe central axis C.

A coaxial bore 65 extends from the bottom of the recess 64 into the headreceiving section 61. The coaxial bore 65 facilitates access with atool, such as a screwdriver, to engage the recess 4 in the head 3 of thebone anchoring element 1.

The locking member 60 further includes a ring portion 66 that extendscompletely around the receiving part 50 and that is monolithic with thecylindrical portion of the locking member 60. In greater detail, thering portion 66 is monolithically connected to the cylindrical portionof the locking member 60 via protrusions 67 which are offset by 180°from one another and that extend through the recesses 57, respectively.The shape of the protrusions 67 is substantially pentagonal andhouse-like shaped with a roof portion oriented towards the top end 6 a.In the axial direction, the height of the protrusions 67 is smaller thanthe height of the recesses 57, so that the locking member 60 can move inthe axial direction by a distance limited by the upper and lower ends ofthe recesses 57. The ring portion 66 is also monolithically connected tothe inner cylindrical portion of the locking member 60 by elevatedportions 66 a that are offset by 180° from one another and that formextensions of the rod support surface 64 a. By means of this, the rodsupport surface is prolonged and extends to the outside of the receivingpart 50.

The ring portion 66 extends from a lower region of the protrusions 67radially outward and downward in the direction of the lower end 5 b ofthe receiving part 50. An inner diameter of the ring portion 66 isslightly greater than an outer diameter of the receiving part in theregion below the recesses 57, so that the ring portion can movedownward. To facilitate the movement of the ring portion 66, thereceiving part 50 may have flattened outer surface portions 500 atpositions corresponding to the circumferential positions of theelevations 66 a. An outer diameter of the ring portion 66 may be thesame or only slightly greater than an outer diameter of the receivingpart 50 in the regions of the tool engagement protrusions 59.

Adjacent to the top end 6 a, the locking member 60 include acircumferential protrusion 68 with a rounded shape that is configured toenter into the rounded groove 58 in the receiving part 50 to preventupward movement of the locking member 60 when the locking member is atan insertion position in which the head 3 can be inserted into the headreceiving section 61.

The locking member 60 is configured to assume a first position relativeto the receiving part in which the head 3 can enter through the loweropening 52 of the receiving part into the head receiving section 61 ofthe locking member 60. Furthermore, the locking member 60 can assume atleast a second position in which the locking member 60 is moved closerto the bottom end 5 b of the receiving part 50 so that the narrowingportions 63 of the locking member 60 and the narrowing portion 53 of thereceiving part engage and an inserted head 3 is prevented from beingremoved from the opening 52. Moreover, in the second position, the head3 may be clamped or finally locked in the receiving part 50. As shown inthe figures, the locking member 60 and the receiving part 50 cannot bedisassembled from each other.

An embodiment of a method of manufacturing the coupling device will bedescribed, with reference to FIGS. 7 to 10 . A preferred manufacturingmethod is an additive layer manufacturing method, whose principles arewell-known in the art. The coupling device is produced consecutivelyfrom layers which correspond to the cross-section of the coupling devicein the respective layer. As an example, a powder bed based layermanufacturing technique, such as selective laser melting (SLM), includesthe steps of applying a layer of building material, such as a powder, inparticular a metal powder or a plastic powder, onto a support surface,and selectively solidifying or melting the powder at positionscorresponding to the cross-section of the coupling device in therespective layer. Subsequently, the steps of applying and meltingfurther layers of the coupling device are repeated until the couplingdevice is finished. The data of the cross-section of the coupling devicein the respective layer and the data for controlling the layermanufacturing apparatus result from CAD or CAM data of the couplingdevice and corresponding slice data.

The receiving part 50 and the locking member 60 are manufactured as amonolithic unit 70, for example, by using such an additive layermanufacturing technique. The monolithic unit 70 is shown in FIGS. 7 to10 and includes a holding portion 71 that is monolithically connectedwith the locking member 60 and also with the receiving part 50. In theexample shown, the holding portion 71 includes a first tube-shapedportion 72 with an upper end 72 a and a lower end 72 b. The upper end 72a is adjacent to the lower end 5 b of the receiving part 50. At theupper end 72 a or close thereto, a second tube-shaped portion 73 extendsupwards that surrounds the lower end of the receiving part 50 with a gap73 a therebetween and that is monolithically connected with the ringportion 66 of the locking element 60. After building up, the monolithicunit 70 is held at the first tube-shaped portion 72 in a machine, and iscut at the two predetermined cutting positions where the holding portion71 is connected to the receiving part 50 and the locking member 60,respectively. The first cutting position is the top end 72 a of thefirst tube portion 72 and the second cutting position 66 b is theintended lower end of the ring portion 66 as shown in FIG. 8 .

The predetermined cutting positions 72 a, 66 b may be marked, forexample, through externally visible markings that are generated duringthe layer-wise build up. For example, the cutting positions may beindicated by a surface structure and/or may have a structure thatfacilitates cutting, such as a weakened structure, for example, aperforated structure or a structure that is less solidified, such thatthe separation after building is more easily facilitated at therespective positions. When the monolithic unit 70 has been built up,unmelted or unsolidified building material can be removed through theopenings which are present in the monolithic unit.

Once separated, the receiving part 50 and the locking member 60 whichform an integrated unit, may be further treated, for example, polished,sand-blasted, etched, or coated. However, in some cases noafter-treatment is carried out, since a rough surface that may resultfrom the building process may be desirable in some applications.

Referring again to FIGS. 1 to 3 , the first member 9 of the fixationassembly 8 is substantially cylindrical and fits into the passage 51 ofthe receiving part 50. Two wings 91 are located at opposite sides of thefirst member 9 and are dimensioned such that they are configured toengage the circumferential recesses 56 in the receiving part 50.Further, the first member 9 defines a passage 92 from a top end to abottom end, where the inner wall preferably has a small number of threadturns 94, preferably only one to three turns for threaded cooperationwith the second member 10. Adjacent to the lower end of the first member9, a recess 93 is formed for receiving an annular projection of thesecond member 10 that prevents the second member 10 from being removedwhen the fixation assembly is in use. The thread may be, for example, aflat thread or square thread. Hence, the threaded connection between thefirst member 9 and the second member 10 is more easy to manufacture, inparticular, when an additive layer manufacturing technique is used. Thesecond member 10 is configured to be arranged in the passage 92. Thesecond member includes an annular projection 101 at its lower end thatis configured to be received in the recess 93 of the first member and toabut against the step 93 a formed by the recess 93. Furthermore, thesecond member 10 includes an outer thread 102 for cooperating with thethread 94 of the first member 9. At a side opposite to the annularprojection 101, the second member 10 has a tool engagement recess 103.

When the first member 9 and the second member 10 are together and theannular projection 101 abuts against the step 93 a, the lower sides ofthe first member and the second member may be flush with each other. Thefirst member 9 and the second member 10 may be manufactured together,preferably with an additive layer manufacturing technique similarly asdescribed in connection with the coupling device 5. The two members maybe manufactured such that they are preliminarily held together by aclamping force, or they may be manufactured as a monolithic unit with adefined breaking section that permits breaking of the connection betweenthe two members when they are moved relative to each other.

The material of the polyaxial bone anchoring device, and in particularof the coupling device and the fixation assembly, may be preferably abody-compatible metal or metal alloy or a body-compatible plasticmaterial. Such a material can be, for example, stainless steel ortitanium or, in the case of a plastic material, polyether ether ketone(PEEK). Such materials are available in powder form for use in theadditive layer manufacturing method as described above.

Steps for assembling the polyaxial bone anchoring device of FIGS. 1 to10 will be described, with reference to FIGS. 11 a and 11 d . In a firststep as shown in FIGS. 11 a , the locking member 60 is in the firstposition which is the insertion position. The rounded protrusion 68engages the rounded groove 58 and the head receiving section 61 is inthe passage 51 at a position where the head receiving section can expandwhen the head 3 is inserted. The head 3 of the bone anchoring element 1is moved towards the opening 52 of the receiving part 50. Next, as shownin FIG. 11 b , the head 3 is inserted through the opening 52 into thehead receiving section 61 of the locking member 60. Since the lockingmember 60 abuts against the upper portion of the groove 58 and/oragainst the upper portion of the recesses 57, a further upward movementof the locking member 60 relative to the receiving part 50 is hindered.

As depicted in FIG. 11 c , the locking member 60 is then moved downwardtowards the second end 5 b of the receiving part 50 until the respectivenarrowing portions 53, 63 of the receiving part and of the lockingmember engage. This is the second position of the locking memberrelative to the receiving part 50. Since the lower opening 52 isnarrowed or otherwise partially blocked by the presence of thecompressed head receiving section 61 of the locking member, the head 3cannot be removed through the opening 52 when the locking member is atthe second position. It shall be noted that the head 3 may also befrictionally held in the head receiving section 61 in the secondposition. This permits the bone anchoring element 1 to be heldtemporarily at a particular angular position relative to the couplingdevice without finally locking the head 3.

Next, as shown in FIG. 11 d , the rod 100 is inserted into the rodchannel until the rod rests on the rod supporting surface 64 a of thelocking member 60. Due to the V-shaped contour of the rod supportingsurface 64 a, it is possible to safely support rods of differentdiameters thereon. Finally, the locking assembly 8 is inserted betweenthe legs 55 of the receiving part 50. This can be achieved by orientingthe first member 9 such that the wings 91 enter the rod channel. Then,the locking assembly 8 is rotated so that the wings 91 engage therecesses 56 until they abut against the abutment 56 a. For fixation ofthe rod 100, the second member 10 is screwed downward until its lowersurface abuts against the rod and fixes the rod. During this step, therod is also moved further downward and presses the locking member 60deeper into the narrowing portion 53 of the receiving part 50 to finallylock the head 3 in the coupling device.

In clinical use, usually two or more polyaxial bone anchoring devicesare connected to the rod 100. In a first way of use, the bone anchoringelement 1 is first inserted into bone, for example, into a pedicle of avertebra, and the coupling device 5 is mounted on the head 3 of the boneanchoring element 1 thereafter. In a second alternative way of use, thebone anchoring element 1 and the coupling device 5 are pre-assembled andinserted in the preassembled condition into the bone, for example, intothe pedicles of adjacent vertebrae.

Referring to FIGS. 12 a to 12 c , steps of operating the polyaxial boneanchoring device will be explained. As depicted in the figures, a frontportion of an instrument 200 includes a pair of elongate first andsecond instrument sections 201, 202 having free ends 201 a, 202 a,wherein the pair is separated by a recess 203. It shall be noted thatthe central first instrument section 201 may be sandwiched between twosecond instrument sections 202 arranged to the left and to the rightthereof. The width of the recess 203 allows the rod 100, and morespecifically the elevations 66 a of the locking member 60, to passtherethrough. The second instrument sections 202 may be connected atsome distance from their free ends by a bridge 204. Further parts of theinstrument 200 include a mechanism for moving the second sections 202relative to the first sections 201. Each of the first sections 201defines, at a distance from the free end 201 a, a recess 201 b that isshaped and sized so as to engage the tool engagement protrusions 59 atthe receiving part 50. The second sections 202 face the othercorresponding second sections 202 on the opposite side of the recess203. Moreover, the second sections 202 can be axially displaced withrespect to the first sections 201. With the instrument 200, it ispossible to move the locking member 60 relative to the receiving part 50from the first position to the second position. In greater detail, asshown in FIG. 12 a , the instrument is oriented relative to the couplingdevice such that the recess 203 and the rod channel are aligned. Thenthe instrument is moved downward to engage the protrusions 59. Thebridge 204 may render the pair of instrument sections slightly flexibleor otherwise able to spread apart with respect to each other, such thatthe front portion can be placed over the receiving part and such thatthe protrusions 59 snap into the recesses 201 b. The free ends 201 a and202 a are resting on the upper surface of the ring portion 66 of thelocking member 60 or are slightly above it. As further depicted in FIG.12 c , the second sections 202 are then moved downwards and press ontothe upper surface of the ring portion 66 to move the locking member 60downwards and deeper into the narrowing portion 53 of the receiving part50. By means of this, the head 3 can be preliminarily held or evenlocked without the rod being in the rod channel. In other words, the rodchannel can remain unobstructed. This permits performing of correctionsteps independent of use of the rod and/or where the rod will not get inthe way of or otherwise hinder performing of any of the correctionsteps. Next, as shown in FIGS. 12 d and 12 e , the rod 100 is insertedand moved down onto the rod support 66 a with a pushing member 205 thatis movable between the pair of instrument sections. Finally, thefixation assembly 8 is inserted and tightened to fix the rod, as shownin FIG. 12 f.

Referring to FIGS. 13 to 18 , a second embodiment of the polyaxial boneanchoring device with a second embodiment of the coupling device will bedescribed. Parts and portions that are identical or similar to the firstembodiment have the same reference numerals, and the descriptionsthereof will not be repeated. The coupling device 5′ includes areceiving part 50′ and a locking member 60′. The receiving part 50′ issubstantially cylindrical and defines a passage that extends fully fromthe top end 5 a to the bottom end 5 b, and a recess 54′ at the top end 5a, by means of which two legs 55′ are formed and which define the rodchannel. The legs 55′ include extensions 55 a that prolong the legs 55′above the top end 5 a of the receiving part 50′. The extensions 55 a maybe broken off later at a weakened breaking section 55 b. Such extensionsmay be useful in minimally invasive surgery (MIS) for guidinginstruments and/or other parts to the implantation site beneath the skinof a patient. An internal thread 56′ may be provided which extends froma portion of the extensions 55 a into the passage below the top end 5 a.In this embodiment, a fixation member 8′ in the form of a set-screw isused that cooperates with the internal thread 56′. A lower portion 501(FIG. 18 ) of the receiving part 50′ adjacent to the bottom end 5 b hasa reduced outer diameter and a reduced wall thickness in a region wherea seat for the head 3 is provided, so that a portion of the lockingmember 60′ can extend into the space resulting from the reduction of theouter diameter of the lower portion.

Referring in particular to FIGS. 14, 16 and 18 , the lower portion ofthe receiving part 50′ adjacent to the bottom end 5 b includes an innernarrowing portion 53′ and a plurality of recesses 502 that are opentowards the lower end 5 b and extend to a distance from the lower end 5b. The end portion 502 a of the recesses 502 may have a triangular orroof-shaped contour. The recesses 502 serve for permitting a portion ofthe locking member 60′ to pass therethrough. In the passage, an enlargedaccommodation space 51 a′ is formed that extends above the narrowingportion 53′ to a distance from the second 5 b and that is configured toreceive an expandable head receiving portion of a separate pressuremember 30 therein.

In addition, as can be seen in particular in FIG. 18 , the receivingpart 50′ includes a plurality of projections 503 on its outer surfacethat may each have a lower inclined and an upper flat surface and thatare configured and shaped to be accommodated in corresponding recessesat an inner wall of the locking member 60′. The projections 503 may bearranged at distances from each other around the circumference of theouter surface of the lower portion 501 of the receiving part 50′.Furthermore, tool engagement protrusions 59′ may also be formed at anouter surface of the legs 55′ that may be asymmetrically arranged withrespect to the rod channel, as can be seen in FIG. 14 .

As shown in FIG. 14 , the separate pressure member 30 has a top end 3 aand a bottom end 3 b, and is arranged in the passage of the receivingpart 50′ such that the bottom end 3 b faces towards the bottom end 5 bof the receiving part 50′. Adjacent to the bottom end 3 b, the pressuremember 30 includes a head receiving portion 31 to receive the head 3 ofthe bone anchoring element 1 therein. The head receiving portion 31 maybe flexible, wherein the flexibility may be achieved by one or moreslits that extend from the bottom end 3 b to a distance thereof. Theouter surface portion 33 adjacent to the bottom end 3 b of the separatepressure member 30 narrows towards the bottom end 3 b, and is configuredto cooperate with the narrowing portion 53′ of the receiving part 50′and with a portion of the locking member 60′. The pressure member 30further includes at a distance from the head receiving portion 31 a rodsupport surface 34 that may have a substantially V-shaped contour andthat is aligned with the rod channel when the pressure member is mountedor otherwise assembled to the receiving part. To the left and to theright of the rod support surface 34, when viewed in a longitudinaldirection of the rod support surface 34, two arms 35 are provided thatare separated from the rod support surface by grooves 36. The endportion of the arms 35 at the top end 3 a of the pressure member 30 havean outward projection 300 that extends into an enlarged section 51 b′ ofthe passage of the receiving part 50′. The arms 35 may be slightlyflexible and may be compressed towards the central longitudinal axis Cof the receiving part 50′ when the separate pressure member 30 isinserted from the free end of the legs 55′ into the receiving part 50′.

The separate pressure member 30 can assume in the receiving part 50′ atleast a first position in which the head receiving portion 31 isexpandable so that a head 3 can be inserted, and a second position inwhich the head receiving portion 31 is at a lower position so that thenarrowing outer surface portion 33 engages the narrowing inner surfaceportion 53′ of the receiving part 50′. In the first position, thepressure member 30 may be secured against moving upward by the outwardprojection 300 of the arms 35 abutting against an upper end of theenlarged section 51 b′ when the head 3 is inserted.

The locking member 60′ forms a ring, or more specifically, forms asleeve that extends around the receiving part 50′. The top end 6 a ofthe locking member 60′ extends up to a distance from the top end 5 a ofthe receiving part 50′. At the bottom end 6 b, the locking member 60′includes inwardly directed projections 63′ at positions that correspondto the recesses 502 in the receiving part 50′. The projections 63′ areconfigured to enter into the recesses 502 at the lower end of thereceiving part 50′. In particular, the projections 63′ may have an innersurface that narrows towards the lower end 6 b of the locking member60′, preferably an inner surface that narrows conically at a same orsimilar angle as the outer surface 33 of the pressure member 30.

Furthermore, in the inner wall of the locking member 60′, recesses 64′are formed at positions corresponding to the projections 503 of thereceiving part 50′ and are configured to accommodate the projections 503and enable a limited movement of the locking member 60′ in the axialdirection relative to the receiving part 50′. The flat upper surfaces ofthe projections 503 abut against the edges of the recesses 64′,respectively, so that the locking member cannot fall off or otherwisedetach from the receiving part. In an upward direction, the lockingmember 60′ would abut against the ends of the recesses 502. Hence, thereceiving part 50′ and the locking member 60′ form an integrated unitand cannot be separated from each other without damaging or destroyingthe respective parts. Lastly, at a distance from the top end 6 a, thelocking member 60′ includes at least one, preferably two opposite toolengagement portions 69′ for engagement with a tool.

It shall be noted that the seat for the head 3 is provided in the headreceiving portion 31 of the pressure member 30. Hence, in thisembodiment, the receiving part 50′ and the pressure member 30, as wellas the portions 63′ of the locking member 60′, together provide the seatfor the head 3.

Referring further to FIG. 15 , a monolithic unit 70′ including thereceiving part 50′ and the locking member 60′ will be described. As inthe first embodiment, the locking member 60′ and the receiving part 50′can be manufactured as one part using an additive layer manufacturingtechnique. The monolithic unit 70′ includes a holding portion 71′ thatis monolithically connected to the locking member 60′ and to thereceiving part 50′. The holding portion 71′ is substantiallysleeve-shaped, and an upper end 71 a of the sleeve continues into thelocking member 60′. For example, the upper end 71 a may be thickened andmay continue into the projection 63′, and simultaneously into the bottomend 5 b of the receiving part 50′. The integrated unit including thelocking member 60′ and the receiving part 50′ is obtained or otherwiseformed by holding the monolithic unit 70′ at the holding portion 71′ andcutting away the upper end 71 a of the monolithic unit 70′, so that as aresult, the locking member 60′ and the receiving part 50′ are movablerelative to each other but cannot be separated from each other. Theinternal thread 56′ in the passage of the receiving part 50′ maypreferably be formed conventionally by thread cutting aftermanufacturing the monolithic unit 70′ or after cutting away theintegrated unit from the holding portion 71′.

In use, the pressure member 30 is pre-assembled with the integratedunit. In contrast to the first embodiment, the locking member 60′ can bemoved upward from a first position in which the pressure member 30 is inan insertion position that permits insertion of the head 3 into the headreceiving section 31, to a second position in which the projections 63′enter or enter farther into the recesses 502 to exert pressure onto theouter surface of the lower narrowing portion 33 of the pressure member30. The head 3 is prevented from removal and can optionally beprovisionally held by friction in the pressure member. Final locking ofthe head 3 can be achieved by inserting the rod 100 and exertingpressure with the fixation member 8′ onto the rod and via the pressuremember 30 onto the head 3.

A third embodiment of the polyaxial bone anchoring device will bedescribed with reference to FIGS. 19 to 24 . Parts and portions that areidentical or similar to the first and second embodiments are indicatedwith the same reference numerals, and the descriptions thereof are notrepeated. The receiving part 50″ in this embodiment is a two-partmember, and the locking member 60″ is a separate ring that isinterconnected with the two parts of the receiving part, such that thelocking member holds the two parts together in such a manner that noneof the parts can be removed or separated from the others withoutdamaging or destroying the integrated unit. As can be seen in particularin FIGS. 20, 23, and 24 , the substantially cylindrical receiving part50″ includes two similar halves 50 a″, 50 b″ that are mirror-symmetricalrelative to a plane spanned by the central axis C and a longitudinalaxis of the rod channel. Each half 50 a″, 50 b″ has a head receivingportion 505, wherein the head receiving portions 505 together form aseat for the head 3 of the bone anchoring element, as shown in FIGS. 23and 24 . Moreover, each of the halves 50 a″, 50 b″ defines half of apassage 511 that extends completely through the receiving part from thetop end 5 a to the bottom end 5 b, and half 504 of a substantiallyU-shaped recess defining a rod channel, so that, similar to the firstembodiment, each half 50 a″, 50 b″ defines a leg 515 of the receivingpart 50″. Circumferentially outer edges of the head receiving portions505 up to a bottom of the substantially U-shaped recess 504 are formedsuch that when the halves 50 a″, 50 b″ are put together, the edges haveonly a limited contact region 510. As a result, the two halves 50 a″, 50b″ can be slightly tilted relative to each other from a first positionthat permits the insertion of the head 3 to a second position in whichthe head 3 is clamped or finally locked.

At the outer surface of the halves 50 a″, 50 b″, two circumferentiallyextending grooves 507 are formed that are configured to accommodate aring shaped portion of the locking member 60″. The size and shape of thegrooves 507 is such that the locking member 60″ is substantiallyrestricted from moving in the axial direction but is able to move in thecircumferential direction, i.e., the locking member can be rotated.

The locking member 60″ is a separate ring that fits into the groove 507.The locking member has two extensions 600 that are offset by 180° andthat extend from the outer surface of the ring downward towards thebottom end 5 b of the receiving part 50″. Also, the extensions arethinner in the radial direction and may be inwardly inclined so that adistance between the extensions narrow with respect to the central axisC as the extensions extend down towards the bottom end 5 b.

The receiving part 50″ further defines, on its outer surface at twoopposite positions offset by 180°, a groove with limited length, or inother words a pocket 508, that extends in the circumferential directionfrom a position that is closer to the rod channel to a position at ornear a middle of the legs 515. The grooves 508 are configured to receivethe extensions 600 of the locking member 60″, respectively. A bottom ofthe groove 508 forms a ramp, by means of which the depth of the groove508 decreases towards the middle of the legs 515. In contrast to therecesses 505 for the head and 504 for the rod, the grooves 508 with theramp are not mirror-symmetrical relative to the plane defined by thecentral axis C and the longitudinal axis of the rod channel. Rather, theposition and the orientation of the ramps are such that, when thelocking member 60″ is rotated, the extensions 600 move along the ramptowards the middle of the legs 515, thereby pressing the two halves 50a″, 50 b″ in the region of the spherical recesses 505 against eachother, so that an inserted head 3 cannot be removed and can be clampedand finally locked.

As shown in FIGS. 21 and 23 , the locking member is in a first positionin which the extensions 600 are spaced apart from the bottom of thegroove 508. As a result, the head receiving recesses 505 can slightlyspread apart to permit insertion of the head 3. As shown in FIGS. 22 and24 , the locking member 60″ has been rotated to a second position inwhich the extensions 600 press against the bottom of the groove 508.Thereby the head receiving recesses 505 are pressed together to clamp orlock the head.

Moreover, the receiving part 50″ defines circumferential recesses 56″for receiving a fixation assembly 8 similar to the fixation assemblyused in the first embodiment. Furthermore, tool engagement recesses 512may be provided on each of the legs at a distance from the top end 5 aof the receiving part 50″.

The coupling device is preferably manufactured using an additive layermanufacturing technology similarly as described in the previousembodiments. Referring to FIGS. 25 and 26 , a monolithic unit 70″ isshown that includes the receiving part 50″ and the locking member 60″ asa single part. The monolithic unit 70″ further includes a holdingportion 71″ that is substantially sleeve-shaped. An upper surface 71 aof the holding portion is monolithically formed with the lower end 5 bof the two halves of the receiving part 50″. From the upper surface, amonolithic connection via a rib 72″ is made to the outside of thelocking member 60″. Hence, the holding portion 71″ is connected at twoportions with the receiving part 50″ and the locking member 60″. Theintegrated unit including the receiving part 50″ and the locking member60″ is obtained by cutting away the holding portion 71″ at the positionof the lower end 5 b of the receiving part 50″ and at a position 72 a″at the outside of the ring portion of the locking member 60″. Thelocking member 60″ cannot fall apart or be otherwise separated from thereceiving part 50″ since the locking member is held in the grooves 507,508.

In use, the coupling device is mounted onto the head 3 of the boneanchoring element 1 with the locking member 60″ in the first position.Then, the locking member 60″ is rotated, for example, with aninstrument, so that the extensions 600 move along the ramp until thelocking member 60″ is in the second position. This results in pressingthe two halves 50 a″, 50 b″ of the receiving part 50″ together so thatthe head receiving portions 505 enclose and clamp the head 3. As shownin FIG. 20 , when the head 3 is locked between the two halves, there maybe a gap 513 between the two halves 50 a″, 50 b″ at the bottom 504 a ofthe recess 504. Inserting the rod 100 and fixing the rod with the secondmember 10 may exert an additional force onto the two halves that furtherlocks the head 3.

Referring to FIGS. 27 to 32 , a fourth embodiment of the bone anchoringdevice and the coupling device will be described. Parts and portions ofthe fourth embodiment that are identical or similar to those of theprevious embodiments are indicated with the same reference numerals, andthe descriptions thereof will not be repeated. The coupling device 5′″according to the fourth embodiment differs from the coupling device 5″according to the third embodiment in that the locking member 60′″ ismonolithically formed with one of the halves of the receiving part. Inaddition, the pockets 508 and the extensions 600 of the third embodimentare not necessary. In greater detail, the receiving part 50′″ includes,similarly to the second embodiment, a first half 50 a′″ and an oppositesecond half 50 b′″ which is at least partially mirror-symmetrical to aplane spanned by the central axis C and the longitudinal axis of the rodchannel, for example, portions of the halves forming the head receivingportion 505 and the rod support 504 a. Each of the halves 50 a′″, 50 b′″includes a head receiving portion 505, a recess 504, and a half of apassage 511 that respectively form the seat for the head, the rodchannel, and the passage. The second half 50 b′″ defines, at a distancefrom the lower end 5 b, a groove 507 b. The first half 50 a′″ ismonolithically connected to a half of a ring 611 that extends around thesecond half 50 b′″ in the groove 507 b. The dimensions of the groove 507b and the ring 611 are such that the two halves 50 a′″, 50 b′″ can beslightly tilted against each other. The half of the ring 611 togetherwith the first half 50 a′″ forms a locking member 60′″. The lockingmember 60′″ can assume a first position in which the head 3 can beinserted into the head receiving portion 505 through the lower opening52 and a second position in which the first half 50 a′″ is tilted withrespect to the second half 50 b′″ to an extent such that an insertedhead 3 cannot be removed from the head receiving portion 505. At adistance from the top end 5 a, a circumferentially extending recess 56′″is provided on each of the legs that serves to receive the fixationassembly 8, which may be identical to the fixation assembly used in thefirst embodiment.

In use, after insertion of the rod 100 and the fixation assembly,tightening of the fixation assembly 8 results in pressure exerted by therod onto the bottom 504 a of the recess 504. Thereby the two halves 50a′″, 50 b′″ are pressed together in the region of the head receivingportion 505 so that an inserted head 3 cannot be removed and can befinally locked.

The two halves 50 a″, 50 b″ are manufactured as a monolithic unit 70′″,as shown in FIG. 32 . As in the previous embodiments, a holding portion71′″ is provided that is substantially sleeve-shaped and is connectedwith its upper end 71 a′″ to the first half 50 a′″ and to the secondhalf 50 b′″ at a position of the lower end 5 b of the receiving part50′″. The integrated unit includes the two halves 50 a′″, 50 b′″,wherein the first half 50 a′″ including the locking member 60′″ isobtained by cutting the monolithic unit at a position corresponding tothe lower end 5 b of the receiving part 50′″.

Further modifications of the above described embodiments are alsoconceivable. In particular, the shape of the parts is not limited to thedetailed shapes shown in the figures. Deviations may be possible andencompassed by the disclosure. It shall be noted that the features ofone embodiment can be also combined with features of other embodiments.For example each of the receiving parts may have extended tabs. Insteadof the fixation assembly, a single set screw may be used in all of theembodiments, or vice versa. For the bone anchoring element, all types ofbone anchoring elements that are suitable for anchoring in bone orvertebra may be used, in particular, also bone nails.

The rod may also have various shapes and/or varying cross-sections alongits length. The rod may be stiff or more flexible.

While the present invention has been described in connection withcertain exemplary embodiments, it is to be understood that the inventionis not limited to the disclosed embodiments, but is instead intended tocover various modifications and equivalent arrangements included withinthe spirit and scope of the appended claims, and equivalents thereof.

1. A coupling device for coupling a rod to a bone anchoring element, thecoupling device comprising: a receiving part having a first end and asecond end below the first end, and comprising a head receiving portiondefining an accommodation space for receiving a head of the boneanchoring element, a rod receiving portion defining a recess forreceiving the rod, a downwardly facing surface, and an upwardly facingsurface below and monolithically formed with the downwardly facingsurface; and a locking member movable relative to the receiving partfrom a first position where the head is insertable into the headreceiving portion to a second position where a maximum size of anopening at the second end of the receiving part is reduced to preventthe head from being removed from the head receiving portion; wherein atleast part of the locking member is held to the receiving part betweenthe downwardly and upwardly facing surfaces.
 2. The coupling device ofclaim 1, wherein the locking member forms at least part of a ring thatextends around the receiving part.
 3. The coupling device of claim 1,wherein the accommodation space forms a seat configured to hold andallow pivoting of the head relative to the seat.
 4. The coupling deviceof claim 3, wherein the seat is radially compressible to clamp the head.5. The coupling device of claim 1, wherein the locking member defines aseat configured to hold and allow pivoting of the head relative to theseat, wherein the seat extends around a portion of the head with agreatest outer width.
 6. The coupling device of claim 1, furthercomprising a separate compression member positionable in the receivingpart that defines a seat configured to hold and allow pivoting of thehead relative to the seat.
 7. The coupling device of claim 1, whereinthe locking member comprises a support surface for the rod.
 8. Thecoupling device of claim 1, wherein the receiving part comprises atleast two separate portions, and wherein the locking member holds the atleast two portions of the receiving part together.
 9. The couplingdevice of claim 8, wherein the locking member is monolithic with atleast one of the at least two portions.
 10. The coupling device of claim8, wherein the at least two portions are tiltable relative to each otherto move the locking member from the first position to the secondposition.
 11. The coupling device of claim 1, wherein the locking memberis rotatable around the receiving part from the first position to thesecond position.
 12. The coupling device of claim 1, wherein the recessfor the rod defines two legs, and wherein the coupling device furthercomprises a fixation assembly engageable with the legs to fix the rodrelative to the receiving part.
 13. The coupling device of claim 12,wherein the fixation assembly comprises a first member and a secondmember movable relative to the first member, wherein the first member isconfigured to be held between the legs in a thread-free manner.
 14. Acoupling device for coupling a rod to a bone anchoring element, thecoupling device comprising: a receiving part comprising a head receivingportion defining an accommodation space for receiving a head of the boneanchoring element and a rod receiving portion defining a recess forreceiving the rod; and a locking member movable relative to thereceiving part from a first position where the head is insertable intothe head receiving portion to a second position where a maximum size ofan opening at the second end of the receiving part is reduced to preventthe head from being removed from the head receiving portion; wherein thelocking member is formed at a position relative to the receiving partwhere a first abutting surface of the receiving part prevents axialmovement of the locking member in a first direction and a secondabutting surface of the receiving part prevents axial movement of thelocking member in a second direction opposite the first direction.15-17. (canceled)
 18. The coupling device of claim 14, wherein thereceiving part and the locking member are formed by an additivemanufacturing method.
 19. The coupling device of claim 18, wherein theadditive manufacturing method comprises a powder based additive layermanufacturing method.
 20. A method of coupling a rod to a bone via abone anchoring device comprising a bone anchoring element comprising ashank and a head, a receiving part having a first end and a second endbelow the first end, and comprising a head receiving portion defining anaccommodation space for receiving a head of the bone anchoring element,a rod receiving portion defining a recess for receiving the rod, adownwardly facing surface, and an upwardly facing surface below andmonolithically formed with the downwardly facing surface, a lockingmember, wherein at least part of the locking member is held to thereceiving part between the downwardly and upwardly facing surfaces, anda fixation assembly, the method comprising: anchoring the shank of thebone anchoring element to bone; inserting the head of the bone anchoringelement into the head receiving portion when the locking member is at afirst position relative to the receiving part; adjusting the lockingmember from the first position to a second position where a maximum sizeof an opening at the second end of the receiving part is reduced toprevent the head from being removed from the head receiving portion;adjusting an angular position of the receiving part relative to thehead; inserting the rod into the recess of the rod receiving portion;and advancing the fixation assembly in the recess of the rod receivingportion to lock the rod and the angular position of the head relative tothe receiving part.